Screen sphere tissue ablation devices and methods

ABSTRACT

The present invention is an ablation device having a screen sphere configuration for the ablation of marginal tissue surrounding a tissue cavity. The device includes a probe having a nonconductive elongated shaft including at least one lumen therethrough and a nonconductive distal portion extending from the shaft. The nonconductive distal portion includes a plurality distal ports and a plurality of proximal ports in communication with the at least one lumen of the shaft. The device further includes an electrode array including a plurality of independent conductive wires extending through the lumen and positioned along an external surface of the nonconductive distal portion, each of the plurality of wires passes through at least an associated one of the proximal ports and through at least a corresponding one of the distal ports.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. Non-Provisionalapplication Ser. No. 17/328,530, filed May 24, 2021, which is acontinuation of U.S. Non-Provisional application Ser. No. 15/828,941,filed Dec. 1, 2017, which is a continuation of U.S. Non-Provisionalapplication Ser. No. 15/624,327, filed Jun. 15, 2017, which is acontinuation of U.S. Non-Provisional application Ser. No. 15/337,334,filed Oct. 28, 2016, which claims the benefit of, and priority to, U.S.Provisional Application No. 62/248,157, filed Oct. 29, 2015, and U.S.Provisional Application No. 62/275,984, filed Jan. 7, 2016, the contentsof each of which are hereby incorporated by reference herein in theirentirety.

FIELD

The present disclosure relates generally to medical devices, and, moreparticularly, to screen sphere tissue ablation devices and methods forablation of marginal tissue surrounding a tissue cavity.

BACKGROUND

Cancer is a group of diseases involving abnormal cell growth with thepotential to invade or spread to other parts of the body. Cancergenerally manifests into abnormal growths of tissue in the form of atumor that may be localized to a particular area of a patient's body(e.g., associated with a specific body part or organ) or may be spreadthroughout. Tumors, both benign and malignant, are commonly treated andremoved via surgical intervention, as surgery often offers the greatestchance for complete removal and cure, especially if the cancer has notspread to other parts of the body. Electrosurgical methods, for example,can be used to destroy these abnormal tissue growths. However, in someinstances, surgery alone is insufficient to adequately remove allcancerous tissue from a local environment.

For example, treatment of early stage breast cancer typically involves acombination of surgery and adjuvant irradiation. Unlike a mastectomy, alumpectomy removes only the tumor and a small rim (area) of the normaltissue around it. Radiation therapy is given after lumpectomy in anattempt to eradicate cancer cells that may remain in the localenvironment around the removed tumor, so as to lower the chances of thecancer returning. However, radiation therapy as a post-operativetreatment suffers various shortcomings. For example, radiationtechniques can be costly and time consuming, and typically involvemultiple treatments over weeks and sometimes months. Furthermore,radiation often results in unintended damage to the tissue outside thetarget zone. Thus, rather than affecting the likely residual tissue,typically near the original tumor location, radiation techniques oftenadversely affect healthy tissue, such as short and long-termcomplications affecting the skin, lungs, and heart.

Accordingly, such risks, when combined with the burden of weeks of dailyradiation, may drive some patients to choose mastectomy instead oflumpectomy. Furthermore, some women (e.g., up to thirty percent (30%))who undergo lumpectomy stop therapy before completing the full treatmentdue to the drawbacks of radiation treatment. This may be especially truein rural areas, or other areas in which patients may have limited accessto radiation facilities.

SUMMARY

Tumors, both benign and malignant, are commonly treated and destroyedvia surgical intervention, as surgery often offers the greatest chancefor complete removal and cure, especially if the cancer has notmetastasized. However, after the tumor is destroyed, a hollow cavity mayremain, wherein tissue surrounding this cavity and surrounding theoriginal tumor site can still leave abnormal or potentially cancerouscells that the surgeon fails, or is unable, to excise. This surroundingtissue is commonly referred to as “margin tissue” or “marginal tissue”,and is the location within a patient where a reoccurrence of the tumormay most likely occur.

The systems and methods described herein can be used during an ablationprocedure to destroy a thin rim of normal tissue around the cavity in aneffort to manage residual disease in the local environment that has beentreated. This technique can help to ensure that all microscopic diseasein the local environment has been treated. This is especially true inthe treatment of tumors that have a tendency to recur. Applications ofsuch a method of intra-operatively extending tumor margins areapplicable to many areas of the body including the liver and especiallythe breast.

In particular, the present disclosure is generally directed to acavitary tissue ablation system including an ablation device to bedelivered into a tissue cavity and emit non-ionizing radiation, such asradiofrequency (RF) energy, to treat the marginal tissue around thetissue cavity. The tissue ablation device of the present inventiongenerally includes a probe including an elongated shaft configured as ahandle and adapted for manual manipulation and a nonconductive distalportion coupled to the shaft. The nonconductive distal portion includesan electrode array positioned along an external surface thereof. Thedistal portion, including the electrode array, can be delivered to andmaneuvered within a tissue cavity (e.g., formed from tumor removal) andconfigured to ablate marginal tissue (via RF energy) immediatelysurrounding the tissue cavity in order to minimize recurrence of thetumor.

In one aspect, the electrode array is composed of a plurality ofconductive members (e.g., conductive wires) electrically isolated andindependent from one another. Thus, in some embodiments, each of theplurality of conductive wires, or one or more sets of a combination ofconductive wires, is configured to independently receive an electricalcurrent from an energy source (e.g., ablation generator) andindependently conduct energy, including RF energy. This allows energy tobe selectively delivered to a designated conductive wire or combinationof conductive wires. This design also enables the ablation device tofunction in a bipolar mode because a first conductive wire (orcombination of conductive wires) can deliver energy to the surroundingtissue through its electrical connection with an ablation generatorwhile a second conductive wire (or combination of conductive wiress) canfunction as a ground or neutral conductive member.

The independent control of each wire or sets of wires allows foractivation (e.g., emission of RF energy) of corresponding portions ofthe electrode array. For example, the electrode array may be partitionedinto specific portions which may correspond to clinical axes or sides ofthe distal portion of the device. In one embodiment, the electrode arraymay include at least four distinct portions (i.e., individual or sets ofconductive wires) corresponding to four clinical axes or sides of thedistal portion (e.g., four sides or quadrants around spheroid body).

In some embodiments, the ablation device is configured to provide RFablation via a virtual electrode arrangement, which includesdistribution of a conductive fluid along an exterior surface of thedistal tip and, upon activation of the electrode array, the fluid maycarry, or otherwise promote, energy emitted from the electrode array tothe surrounding tissue. For example, the nonconductive distal portion ofthe ablation device includes an interior chamber retaining at least aspacing member (e.g., spacer ball) and a hydrophilic insert surroundinga spacing member. The interior chamber of the distal portion isconfigured to receive and retain a fluid (e.g., saline) therein from afluid source. The hydrophilic insert is configured receive and evenlydistribute the fluid through the distal tip by wicking the fluid againstgravity. The even distribution is independent of probe orientation. Theinsert also serves as a fluid flow resistance, preventing all of thefluid from pooling out of the irrigation ports too quickly. The distalportion may generally include a plurality of ports or aperturesconfigured to allow the fluid to pass therethrough, or weep, from theinterior chamber to an external surface of the distal portion. Thespacer member is shaped and sized so as to maintain the hydrophilicinsert in contact with the interior surface of the distal tip wall, andspecifically in contact with the one or more perforations, such that thehydrophilic insert provides uniformity of fluid distribution to theperforations. Accordingly, upon positioning the distal portion within atarget site (e.g., tissue cavity to be ablated), the electrode array canbe activated. The fluid weeping through the perforations to the outersurface of the distal portion is able to carry energy from electrodearray, thereby creating a virtual electrode. Accordingly, upon the fluidweeping through the perforations, a pool or thin film of fluid is formedon the exterior surface of the distal portion and is configured toablate surrounding tissue via the RF energy carried from the electrodearray.

It should be noted the devices and methods of the present disclosure arenot limited to such post-surgical treatments and, as used herein, thephrase “body cavity” may include non-surgically created cavities, suchas natural body cavities and passages, such as the ureter (e.g. forprostate treatment), the uterus (e.g. for uterine ablation or fibroidtreatment), fallopian tubes (e.g. for sterilization), and the like.Additionally, or alternatively, tissue ablation devices of the presentdisclosure may be used for the ablation of marginal tissue or surfacetissue in various parts of the body and organs (e.g., lungs, liver,pancreas, etc.) and is not limited to treatment of breast cancer.

The present disclosure includes ablation devices consistent with thepresent invention that have a refined design, which is amenable to fastand simple methods of manufacturing. Accordingly, the present disclosurealso provides methods for manufacturing such ablation devices.

An exemplary method for manufacturing a medical device of the inventionincludes: providing elongate body comprising an interior space as twocomplimentary halves, wherein each half comprises a spheroid body at adistal end; providing two wire harnesses, each wire harness comprising aplurality of electrically isolated wires, each wire comprising aconductive distal end; looping the conductive distal end of each wirearound an anchor member disposed on a distal portion of the spheroidbody of one of the complimentary body halves, such that two portions ofeach conductive distal end are disposed along a surface of the spheroidbody; and joining the two complimentary halves. The conductive wires mayalso be anchored via a physical termination at the end of the wire, andthe termination can be comprised of conductive or nonconductivematerial.

In certain aspects, the conductive distal ends of each wire arepreformed loops. Looping the conductive distal end of a wire may includedisposing a preformed loop along the exterior surface of the spheroidbody and fastening the anchor to a distal portion of the spheroid body.In certain aspects, looping the conductive distal end of a wire includespassing the conductive distal end from the interior space of an elongatebody half to an exterior side, distally along the exterior surface ofthe spheroid body, around the anchor member, proximally along theexterior surface, and through the body into the interior space.

In certain methods, prior to joining the complimentary halves, each wireharness is connected to a central electrical wire disposed within theinterior space of the elongate body. A portion of each wire harness maybe seated within one or more channels disposed on an interior surface ofan elongate body half. In certain aspects, a portion of central wire isseated within one or more channels disposed on an interior surface of anelongate body half.

Certain methods of the invention include seating a hydrophilic insert inat least one spheroid body. The hydrophilic insert may be a spheroid.The hydrophilic insert may have a unique shape to fit the interiorsurface of the complimentary halves, which may include structural ridgesor mating features. The hydrophilic insert may also include a sphericalspacer ball disposed within an interior of the insert. The hydrophilicinsert may be provided as two complementary halves that are joinedaround the spacer prior to seating. The hydrophilic insert may beattached to the spacer ball.

In certain aspects, the method includes seating at least one fluid lumenwithin the interior space of an elongate body half. The method mayfurther include seating a distal fluid lumen and a proximal fluid lumeninto the interior space of the elongate body half and fluidicallyconnecting the lumens. The lumens may be connected using a fluidicconnector seated between the lumens.

In certain aspects, a fluidic connector may be inserted into the neck ofthe device to prevent fluid from flowing into the handle. The fluidicconnector may complete an air- or leak-tight seal, with or without theaid of adhesive or liquid silicone to complete the seal.

In certain aspects, the spacer ball may serve as a method for mating thetwo complimentary halves together. The complimentary halves may includeridges that provide structural support and/or are part of the matingconfiguration.

In certain aspects, the electrical connections between the twocomplimentary halves may be made using conductive components that matewhen the two halves come together. The electrodes may terminate in theseconductive components. The two conductive components may mate togethervia a configuration of male and female parts. In certain aspects, afterjoining the elongate body halves, the method further includes seating adistal cap on the distal end of the joined spheroid bodies. In certainmethods, seating the distal cap secures the looped conductive distalends around the anchor members.

In certain methods, the distal spheroid bodies include a plurality ofsupport members, each member extending from a proximal portion of thespheroid body to the distal portion, wherein a distal end of each memberis attached to the distal portion of the spheroid body via one of theanchor members. The method may further include passing each of the twoconductive wire portions of each wire along a lateral surface of one ofthe support members. Certain methods of the invention include passingeach of the two conductive wire portions of each wire underneath a oneor the support members. In certain aspects, the support members areconductive.

In certain aspects, the controller may be powered by a battery and thebattery may be held in place using an overlay. The overlay may contain aperforated section that allows the user to tear away a portion of theoverlay in order to remove the battery after use. The overlay may have afoam backing which prevents fluid ingress from seeping into the batteryslot. The overlay's perforation may be located outside of the batterywindow in order to prevent fluid ingress.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the claimed subject matter will be apparentfrom the following detailed description of embodiments consistenttherewith, which description should be considered with reference to theaccompanying drawings, wherein:

FIG. 1 is a schematic illustration of an ablation system consistent withthe present disclosure;

FIG. 2 is a perspective view of an ablation device tip of the ablationsystem of FIG. 1; FIGS. 3A, 3B, and 3C are perspective views of theablation device tip of FIG. 2 in greater detail;

FIGS. 4A and 4B schematically illustrate the ablation device tip of theablation device of FIG. 1 with and without the nonconductive distalportion, respectively;

FIG. 5A is a side view and FIG. 5B is a cross-sectional view of oneembodiment of a deployable distal portion of the ablation deviceillustrating transitioning of the distal portion from a deliveryconfiguration to a deployed configuration;

FIG. 6 illustrates a method of deploying the distal portion of FIGS. 5Aand 5B into an expanded configuration for delivery of RF energy to atarget site for ablation of marginal tissue;

FIG. 7 is a cross-sectional view of the deployable distal portion ofFIGS. 5A and 5B illustrating the inclusion of an internal balloon memberwithin an interior chamber of the distal portion. The internal balloonis configured to receive a fluid from a fluid source and thereby expand,which, in turn, causes the distal portion to transition from thedelivery configuration to the deployed configuration, and further supplythe fluid to an exterior surface of the distal portion, via weeping ofthe fluid through one or more perforations on the distal portion wall,to create a virtual electrode arrangement with the electrode array;

FIG. 8 is an exploded view of an ablation device consistent with thepresent disclosure, including a hydrophilic insert provided within aninterior chamber of the distal portion and configured to receive a fluidfrom a fluid source and evenly distribute the fluid to an exterior anexterior surface of the distal portion, via weeping of the fluid throughone or more perforations on the distal portion wall, to create a virtualelectrode arrangement with the electrode array;

FIG. 9 is an exploded view of the ablation device of FIG. 8 illustratingthe hydrophilic insert in more detail;

FIGS. 10A-10E are perspective views of a distal tip of the ablationdevice of FIG. 1 illustrating various electrode array configurations;

FIG. 11 is a side view of the distal tip of the ablation device of FIG.1 including several clinical axes or sides. Each clinical axis or sideincludes one or more independently connected electrodes, which enablesdifferential function and current independent drives and/ormeasurements;

FIGS. 12A-12D are side and perspective views of the distal tip of theapplication device illustrating the different clinical axes or sides ofFIG. 11;

FIGS. 13A-13C are perspective views of various embodiments of a devicecontroller consistent with the present invention;

FIG. 14 shows an exploded perspective view, of the device controllershown in FIG. 13A;

FIG. 15 is an exploded perspective view of another embodiment of anablation device consistent with the present disclosure;

FIG. 16 is a plan view of the ablation device of FIG. 15 illustratingthe two halves of the device separated from one another and showing theexternal surface of each;

FIG. 17 is a plan view of the ablation device of FIG. 15 illustratingthe two halves of the device separated from one another and showing theinterior surface of each;

FIGS. 18A and 18B are enlarged views of the spheroid body of the firsthalve of the device showing the exterior and interior surfaces,respectively, and further illustrating the particular arrangement offirst and second conductive wires extending through proximal and distalports of the spheroid body;

FIGS. 19A and 19B are enlarged views of the spheroid body of the secondhalve of the device showing the exterior and interior surfaces,respectively, and further illustrating the particular arrangement ofthird and fourth conductive wires extending through proximal and distalports of the spheroid body;

FIG. 20 is a schematic illustration of the ablation device of FIG. 15illustrating delivery of fluid from the irrigation pump, as controlledby the controller, to the hydrophilic insert within the interior chamberof the distal portion of the device, wherein the fluid can besubsequently distributed to an exterior surface of the distal portionresulting in a virtual electrode arrangement upon activation of one ormore portions of the electrode array;

FIG. 21 is a perspective view of a detachable mount for holding atemperature probe (or any other separate monitoring device) at a desiredposition relative to the distal portion of the ablation device for thecollection of temperature data during an RF ablation procedure;

FIG. 22 is a plan view of the detachable mount holding the temperatureprobe relative to the distal portion of the ablation device;

FIG. 23 shows a perspective view of an exemplary ablation device of theinvention;

FIG. 24 shows an exploded view of an exemplary ablation device of theinvention.

FIG. 25 shows a cutaway view of an exemplary ablation device of theinvention.

FIG. 26 shows a perspective view an exemplary ablation device of theinvention; and

FIG. 27 shows a perspective view of the distal end of an ablation deviceof the invention.

For a thorough understanding of the present disclosure, reference shouldbe made to the following detailed description, including the appendedclaims, in connection with the above-described drawings. Although thepresent disclosure is described in connection with exemplaryembodiments, the disclosure is not intended to be limited to thespecific forms set forth herein. It is understood that various omissionsand substitutions of equivalents are contemplated as circumstances maysuggest or render expedient.

DETAILED DESCRIPTION

By way of overview, the present disclosure is generally directed to atissue ablation device having a deployable applicator head configured tobe delivered into a tissue cavity and ablate marginal tissue surroundingthe tissue cavity.

A tissue ablation system consistent with the present disclosure may bewell suited for treating hollow body cavities, such asirregularly-shaped cavities in breast tissue created by a lumpectomyprocedure. For example, once a tumor has been removed, a tissue cavityremains. The tissue surrounding this cavity is the location within apatient where a reoccurrence of the tumor may most likely occur.Consequently, after a tumor has been removed, it is desirable to destroythe surrounding tissue (also referred herein as the “margin tissue” or“marginal tissue”).

The tissue ablation system of the present disclosure can be used duringan ablation procedure to destroy the thin rim of marginal tissue aroundthe cavity in a targeted manner. In particular, the present disclosureis generally directed to a cavitary tissue ablation system including anablation device to be delivered into a tissue cavity and configured toemit non-ionizing radiation, such as radiofrequency (RF) energy, in adesired shape or pattern so as to deliver treatment for the ablation anddestruction of a targeted portion of marginal tissue around the tissuecavity.

The tissue ablation device of the present invention generally includes aprobe including an elongated shaft configured as a handle and adaptedfor manual manipulation and a nonconductive distal portion coupled tothe shaft. The nonconductive distal portion includes an electrode arraypositioned along an external surface thereof. The distal portion,including the electrode array, can be delivered to and maneuvered withina tissue cavity (e.g., formed from tumor removal) and configured toablate marginal tissue (via RF energy) immediately surrounding thetissue cavity in order to minimize recurrence of the tumor. The tissueablation device of the present disclosure is configured to allowsurgeons, or other medical professionals, to deliver precise, measureddoses of RF energy at controlled depths to the marginal tissuesurrounding the cavity.

Accordingly, a tissue ablation device consistent with the presentdisclosure may be well suited for treating hollow body cavities, such asirregularly-shaped cavities in breast tissue created by a lumpectomyprocedure. It should be noted, however, that the devices of the presentdisclosure are not limited to such post-surgical treatments and, as usedherein, the phrase “body cavity” may include non-surgically createdcavities, such as natural body cavities and passages, such as the ureter(e.g. for prostate treatment), the uterus (e.g. for uterine ablation orfibroid treatment), fallopian tubes (e.g. for sterilization), and thelike. Additionally, or alternatively, tissue ablation devices of thepresent disclosure may be used for the ablation of marginal tissue invarious parts of the body and organs (e.g., skin, lungs, liver,pancreas, etc.) and is not limited to treatment of breast cancer.

FIG. 1 is a schematic illustration of an ablation system 10 forproviding targeted ablation of marginal tissue during a tumor removalprocedure in a patient 12. The ablation system 10 generally includes anablation device 14, which includes a probe having a distal tip orportion 16 and an elongated catheter shaft 17 to which the distal tip 16is connected. The catheter shaft 17 may generally include anonconductive elongated member including a fluid delivery lumen. Theablation device 14 may further be coupled to a device controller 18 andan ablation generator 20 over an electrical connection (electrical line34 shown in FIG. 2), and an irrigation pump or drip 22 over a fluidconnection (fluid line 38 shown in FIG. 2). The ablation generator 20may also connected to a return electrode 15 that is attached to the skinof the patient 12.

As will be described in greater detail herein, the device controller 18may be used to control the emission of energy from one or moreconductive members of the device 14 to result in ablation, as well ascontrolling the delivery of fluid to the applicator head 16 so as tocontrol subsequent weeping of fluid from the head 16 during an RFablation procedure. In some cases, the device controller 18 may behoused within the ablation device 14. The ablation generator 20 may alsoconnected to a return electrode 15 that is attached to the skin of thepatient 12.

As will be described in greater detail herein, during an ablationtreatment, the ablation generator 20 may generally provide RF energy(e.g., electrical energy in the radiofrequency (RF) range (e.g., 350-800kHz)) to an electrode array of the ablation device 14, as controlled bythe device controller 18. At the same time, saline may also be releasedfrom the head 16. The RF energy travels through the blood and tissue ofthe patient 12 to the return electrode 15, as shown in FIG. 1, or areturn electrode on the distal head 16 itself. In the process, theenergy ablates the region(s) of tissues adjacent to portions of theelectrode array that have been activated.

FIG. 2 is a perspective view of the distal portion or tip 16 of theablation device 14. The distal tip 16 may include a neck portion 24 anda generally spheroid body 26 extending distally from the neck 24. Itshould be noted that, in some embodiments, the spheroid body 26 may begenerally rigid and may maintain a default shape. However, in someembodiments, the spheroid body 26 may be configured to transitionbetween a collapsed state and an expanded state, as will be described ingreater detail herein, particular with respect to FIGS. 5A-5B and 6-7.For example, the spheroid body 26 may be collapsible to a deliveryconfiguration having a reduced size (e.g., equatorial diameter) relativeto the deployed configuration size (e.g., equatorial diameter) of thespheroid body 26.

In some examples, the spheroid body 26 includes a non-conductivematerial (e.g., a polyamide) as a layer on at least a portion of aninternal surface, an external surface, or both an external and internalsurface. In other examples, the spheroid body 26 is formed from anon-conductive material. Additionally or alternatively, the spheroidbody 26 material can include an elastomeric material or a shape memorymaterial.

In some examples, the spheroid body 26 has a diameter (e.g., anequatorial diameter) of about 80 mm or less. In certain implementations,the spheroid body 26 of the distal tip, in a deployed configuration, hasan equatorial diameter of 2.0 mm to 60 mm (e.g., 5 mm, 10 mm, 12 mm, 16mm, 25 mm, 30 mm, 35 mm, 40 mm, 50 mm, and 60 mm). Based on the surgicalprocedure, the collapsibility of the spheroid body 26 can enable thedistal tip to be delivered using standard sheaths (e.g., an 8Fintroducer sheath). However, the spheroid body 26 need not becollapsible in some procedures, and thus has a relatively rigid body andmaintains the default shape.

The distal tip 16 of the ablation device 14 further includes anelectrode array positioned thereon. The electrode array includes atleast one conductive member 28. As illustrated in the figures, theelectrode array may includes at least eight conductive members 28.Accordingly, the electrode array may include a plurality of conductivemembers 28. The plurality of conductive members 28 extend within thedistal tip 16, through a channel 32 and along an external surface of thespheroid body 26. The conductive members 28 extend along thelongitudinal length of the distal tip 16 and are radially spaced apart(e.g., equidistantly spaced apart) from each other. These conductivemembers transmit RF energy from the ablation generator and can be formedof any suitable conductive material (e.g., a metal such as stainlesssteel, nitinol, or aluminum). In some examples, the conductive members28 are metal wires. Accordingly, for ease of description, the conductivemember(s) will be referred to hereinafter as “conductive wire(s) 28”.

As illustrated, one or more of the conductive wires 28 can beelectrically isolated from one or more of the remaining conductive wires28. This electrical isolation enables various operation modes for theablation device 14. For example, ablation energy may be supplied to oneor more conductive wires 28 in a bipolar mode, a unipolar mode, or acombination bipolar and unipolar mode. In the unipolar mode, ablationenergy is delivered between one or more conductive wires 28 on theablation device 14 and the return electrode 15, as described withreference to FIG. 1. In bipolar mode, energy is delivered between atleast two of the conductive wires 28, while at least one conductive wire28 remains neutral. In other words, at least, one conductive wirefunctions as a grounded conductive wire (e.g., electrode) by notdelivering energy over at least one conductive wire 28.

The electrode array may further include one or more stabilizing members30 configured to provide support for the plurality of conductive wires28. The one or more stabilizing member 30 generally extend along asurface (e.g., external or internal) of the distal tip 16 so as tocircumscribe the spheroid body 26. The stabilizing members 30 can, insome examples, electrically connect to one or more conductive wires 28.In other examples, the stabilizing members 30 are non-conductive. Thestabilizing members 30 can be formed of a suitably stiff material (e.g.,metal such as stainless steel, nitinol, or aluminum). In someimplementations, the stabilizing members 30 can be integral with aportion of the spheroid body 26 (e.g., as a rib). While, the distal tip16 is generally shown with one or more stabilizing members, in someimplementations, the distal tip 16 is free of stabilizing members.

To further aid in illustrating the arrangement of the conductive wires28 and the non-conductive spheroid body 26, FIG. 4A shows the conductivewires 28 positioned over the non-conductive spheroid body 26 while FIG.4B shows the electrode array of the ablation device without thenon-conductive spheroid body 26.

As shown, the distal tip 16 may be coupled to the ablation generator 20and/or irrigation pump 22 via an electrical line 34 and a fluid line 38,respectively. Each of the electrical line 34 and fluid line 38 mayinclude an adaptor end 36, 40, respectively, configured to couple theassociated lines with a respective interface on the ablation generator20 and irrigation pump 22. In some examples, the ablation device 14 mayfurther include a user switch or interface 19 which may serve as thedevice controller 18 and thus, may be in electrical communication withthe ablation generator 20 and the ablation device 14, as well as theirrigation pump 22 for controlling the amount of fluid to be deliveredto the tip 16.

The switch 19 can provide a user with various options with respect tocontrolling the ablation output of the device 14, as will be describedin greater detail herein. For example, the switch 19, which may serve asthe device controller 18, may include a timer circuit, or the like, toenable the conductive wires 28 to be energized for a pre-selected ordesired amount of time. After the pre-selected or desired amount of timeelapses, the electrical connection can be automatically terminated tostop energy delivery to the patient. In some cases, the switch 19 may beconnected to individual conductive wires 28. For example, in someembodiments, the switch 19 may be configured to control energy deliveryfrom the ablation generator 20 so that one or more individual conductivewires, or a designated combination of conductive wires, are energizedfor a pre-selected, or desired, duration.

FIGS. 3A, 3B, and 3C are perspective views of the distal tip 16 of FIG.2 in greater detail. As shown in FIGS. 2 and 3A-3C, the conductive wires28 extend through a lumen 42 within the distal tip 16. For example, eachof the conductive wires 28 enters the lumen 42 of the neck 27 andextends through the distal tip portion 16 before exiting the distal tipthrough either a center channel 32 at a distal most portion of thedistal tip or one of a plurality of proximal ports 44. In some examples,a plurality of distal ports 46 extending through a wall of the distaltip 16 is positioned around the channel 32. A plurality of proximalports 44 can also extend through a wall of the distal tip 16. Theseproximal ports 44 can be positioned around the distal tip 16 in closeproximity (e.g., within at least 5 mm, within at least 3 mm, within atleast 1 mm, within 0.5 mm, within 0.4 mm, or within 0.2 mm) to thejunction between the spheroidal body 26 and the neck 24 of the distaltip 16. In some cases, the number of proximal ports 44 and distal ports46 is equal to the number of conductive wires 28.

In some examples, each conductive wire 28 can extend through a differentdistal port 46, which allows the conductive wires 28 to remainelectrically isolated from one another. In other examples, one or moreconductive wires can extend through the same distal port 46.

Upon passing through a distal port 46, each conductive wire 28 canextend along an external surface of the distal tip 16. In some examples,the length of the conductive wire 28 extending along the externalsurface is at least 20% (e.g., at least, 50%, 60%, 75%, 85%, 90%, or99%) of the length of the spheroid body 26. The conductive wire 28 canthen re-enter the lumen 42 of the distal tip 16 through a correspondingproximal port 44. For example, as shown in FIG. 3C, conductive wire28(1) passes through distal port 46(1), extends along a length of theexternal surface of the distal tip 16, and passes through an associatedproximal port 44(1) into the lumen 42 of the distal tip 16, whileconductive wire 28(2) is electrically isolated from conductive wire28(1) in that it passes through associated proximal and distal ports44(2), 46(2), respectively.

In some examples, each conductive wire 28 can extend through a differentassociated proximal port 44, which allows the conductive wires 28 toremain electrically isolated from one another. In other examples, one ormore conductive wires can extend through the same proximal port. Yetstill, as will be described in greater detail herein, particularly withreference to the device 14 a illustrated in FIGS. 18A-18B and 19A-19B,an individual conductive wire can extend through multiple proximal anddistal ports.

In some embodiments, the spheroid body 26 may be configured totransition between a collapsed state and an expanded state, which mayallow for a surgeon to introduce the distal portion 26 into certainareas of the body that may have reduced openings and could be difficultto access with when the spheroid body is in the default shape. FIG. 5Ais a side view and FIG. 5B is a cross-sectional view of one embodimentof a deployable distal portion 26 of the ablation device 14 illustratingtransitioning of the distal portion 26 from a delivery configuration toa deployed configuration.

As shown, when in a delivery configuration, the spheroid body 26 maygenerally have a prolate-spheroid shape, thereby having a reduced size(e.g., equatorial diameter) relative to the deployed configuration size(e.g., equatorial diameter). In some embodiments, the spheroid body 26may be configured to transition between the delivery and deployedconfigurations via manipulation of one or more of the conductive wires.For example, as shown in FIG. 5B, at least one conductive wire 28 may beconfigured to translate axially along a longitudinal axis of the distaltip 16, which, in turn, can exert a force on at least a region of thedistal tip 16 that causes or partially causes the spheroid body 26 totransition or deform between a delivery configuration to a deployedconfiguration. For example, axial translation of the conductive wire 28along an axial direction exerts a force on the distal tip 16, whichcauses spheroid body 26 to assume a more spherical configuration fordeployment. In other words, axially translating the conductive wire 28causes the spheroid body 26 to transition from a delivery configurationin which the spheroid body 26 exhibits a prolate-spheroid shape to adeployment configuration in which the spheroid body 26 exhibits anoblate-spheroid shape.

FIG. 6 illustrates a method of deploying the distal portion 16 into anexpanded configuration for delivery of RF energy to a target site forablation of marginal tissue. As shown, the method includes inserting thecannula into a body cavity 691. The inner tube, which is a cathetershaft 17 pushes 692 the spheroid body 26 out of the cannula. This caninclude using a first control knob. The spheroid body 26 naturallyexpands 693 when released from the cannula. To complete expansion andforming the spheroid body into a spheroid shape, a second knob slides694 in a proximal direction 50 to retract one or more conductive wiresuntil the full spherical shape is achieved in the spheroid body 26. Thesecond knob can be locked 695 into position and the one or moreconductive wires can be activated to start ablation.

As shown, the catheter shaft 17 of the ablation device 14 can optionallyinclude a dedicated control wire connected to a knob or controlmechanism accessible on the catheter shaft. In this example, one or morecontrol wires or other components may be coupled to the conductive wiresto control the retraction and expansion (e.g., via pushing alongdirection 48 and pulling along direction 50) of the distal tip 15 fromthe catheter shaft 17. In addition, other components (e.g., electricalwiring for electrically coupling the conductive element and RFgenerator) can also be housed within the, at least, one lumen of thecatheter shaft 17 of the ablation device 14.

In some implementations, the catheter shaft 17 can be configured as ahandle adapted for manual manipulation. In some examples, the cathetershaft 17 is additionally or alternatively configured for connection toand/or interface with a surgical robot, such as the Da Vinci® surgicalrobot available from Intuitive Surgical, Inc., Sunnyvale, Calif. Thecatheter shaft 17 may be configured to be held in place by a shape lockor other deployment and suspension system of the type that is anchoredto a patient bed and which holds the device in place while the ablationor other procedure takes place, eliminating the need for a user tomanually hold the device for the duration of the treatment.

FIG. 7 is a cross-sectional view of the deployable distal portion ofFIGS. 5A and 5B illustrating the inclusion of an internal balloon memberwithin an interior chamber of the distal portion 26. The internalballoon is configured to receive a fluid from a fluid source and therebyexpand, which, in turn, causes the distal portion to transition from thedelivery configuration to the deployed configuration, and further supplythe fluid to an exterior surface of the distal portion, via weeping ofthe fluid through one or more perforations on the distal portion wall(e.g., distal port 46), to create a virtual electrode arrangement withthe electrode array. For example, the inner balloon may include aplurality of perforations, holes, or micropores in the balloon wall soas to allow a fluid provided within the balloon (e.g., saline) to passtherethrough, or weep, from the balloon when the balloon is inflated.The perforations may be sized, shaped, and/or arranged in such a patternso as to allow a volume of fluid to pass from the interior volume of theballoon into the interior chamber of the distal portion 26 and then topass through one or more perforations, holes, or micropores formed inthe distal portion wall to an exterior surface of the tip at acontrolled rate so as to allow the balloon to remain inflated andmaintain its shape.

FIG. 8 is an exploded view of an ablation device 14 consistent with thepresent disclosure. As shown, in some implementations, the ablationdevice 14, specifically the distal tip 16, may be formed from two ormore pieces (tip halves 16 a and 16 b) configured to be coupled to oneanother to form the unitary distal tip 16. Each half 16 a and 16 bincludes cooperating neck portions 24 a, 24 b and spheroid bodies 26 a,26 b, as well as a cap 52 to be coupled to both halves 16 a and 16 b soas to fully enclose the interior of the distal tip 16. As furtherillustrated, an electrical line 34 may be provided for coupling theconductive wires 28 to the controller 18 and ablation generator 20 and afluid line 38 may be provided for providing a fluid connection betweenthe irrigation pump or drip 22 to the distal tip 16 so as to provide aconductive fluid (e.g., saline) to the tip 16. The electrical line 34and/or the fluid delivery line 38 can be supported by a stabilizingelement 62 within the device lumen. In some cases, the stabilizingelement 62 may be integral with the neck 24 of the distal tip 16.

As previously described, conductive members 28 extend through a firstport (e.g., the distal port 44), run along an external surface of thespheroid body 26 (e.g. within the groove 47) before re-entering thelumen of the distal tip 16 through another port (e.g., the proximal port46). A conductive fluid, such as saline, may be provided to the distaltip 16 via the fluid line 38, wherein the saline may be distributedthrough the ports (e.g., to the distal ports 44, the proximal ports 46,and/or medial ports 45). The saline weeping through the ports and to anouter surface of the distal tip 16 is able to carry electrical currentfrom electrode array, such that energy is promoted from the electrodearray to the tissue by way of the saline weeping from the ports, therebycreating a virtual electrode. Accordingly, upon the fluid weepingthrough the ports, a pool or thin film of fluid is formed on theexterior surface of the distal tip 16 and is configured to ablatesurrounding tissue via the electrical current carried from the electrodearray.

As shown, the ablation device 14 may further include hydrophilic insert54 aligned with the fluid delivery line 38 and positioned within theinterior chamber formed between the two halves 16 a, 16 b. Thehydrophilic insert 40 is configured to distribute fluid (e.g., saline)delivered from the fluid line 38 through the distal tip 16 by, forexample, wicking the saline against gravity. This wicking actionimproves the uniformity of saline distribution to the device ports(e.g., to the proximal ports 44, the distal ports 46, and/or a medialports 45). The hydrophilic insert 40 can be formed from a hydrophilicfoam material (e.g., hydrophilic polyurethane).

As shown in FIG. 9, for example, a conductive wire 28 passes within alumen 64 of the hydrophilic insert 40 and along an external surfacethereof. Similar to the conductive wires 28, the conductive wire 28passing through the hydrophilic insert 54 is also electrically connectedto the ablation generator 20. In some embodiments, the conductive member28 is also configured to deploy the hydrophilic insert 40 from adelivery configuration to a deployed configuration (e.g., deployed asshown). For example, during use, the conductive member 28 can alsocontract or expand the hydrophilic insert 40 to modify the saline fluidflow as desired. For example, a control wire 58 may pass within thelumen of the tip 16, and may be grouped with other control wires (notshown) into a control line 56 that extends through the device lumenalongside the fluid delivery line 38. The control wires 58 can beconnected to the conductive members 28 by a conductive link 60.

FIGS. 10A-10E are perspective views of a distal tip of the ablationdevice of FIG. 1 illustrating various electrode array configurations. Inaddition, while the conductive wires 28 have been described as extendingalong an external surface of the distal tip 16 in a direction that isparallel to the longitudinal axis of the device (as shown in alongitudinal configuration of conductive wires 28 a in FIG. 10A), otherconfigurations are possible. For example, one or more conductive wires28 b could extend along the external surface of the distal tip 16 in adirection that is perpendicular to the longitudinal axis of the device(as shown in a circumferential configuration in FIG. 10B). In otherexamples, one or more conductive wires 28 c can extend from along theexternal surface of the distal tip 16 at an angle (e.g., non-parallel tothe longitudinal axis of the device), as shown in an angledconfiguration in FIG. 10C. One or more conductive wires 28 d, 28 e, and28 f can also form a pattern along the external surface in which theconductive wires extend in various directions, as shown in a combinedconfiguration in FIG. 10D. Additionally or alternatively, one or moreconductive wires 28 g can extend a reduced length of the externalsurface an alternative configuration in FIG. 10E.

While various conductive wires 28 have generally been described suchthat individual conductive members are energized or that the desiredcombination of conductive members is energized for a pre-selected ordesired duration, in some cases, the desired combination of conductivemembers can be based on desired contact region of the distal tip 16.

FIG. 11 is a side view of the distal tip 16 of the ablation device 14 ofFIG. 1 including several clinical axes or sides. Each clinical axis orside includes one or more independently connected electrodes, whichenables differential function and current independent drives and/ormeasurements. For example, referring to FIG. 11, the distal tip 16 canbe divided into clinical axes or sides 66, 68, 70, 72, 74, and 75 (notshown). In other words, the distal tip 16 may include six clinical axesor sides of the distal portion (e.g, four sides or quadrants aroundspheroid body 70, 72, 74, and 75, and a top axis/side 66, and a bottomaxis/side 68).

FIGS. 12A-12D are side and perspective views of the distal tip of theapplication device illustrating the different clinical axes or sides ofFIG. 9. As shown in FIGS. 12A-12D, each clinical axis can includemultiple independently connected conductive wires. For example, clinicalaxis/side 66 can include three independently connected conductive wires76, clinical axis/side 68 can include three independently connectedconductive wires 78, clinical axis/side 70 can include threeindependently controlled conductive wires 80, clinical axis/side 72 caninclude three independently connected conductive wires 82, clinicalaxis/side 74 can include three independently controlled conductive wires84, and clinical axis/side 75 can include three independently controlledconductive wires 86. The independently connected conductive wires withineach clinical axis or side allows for differential function andindependent energy delivery and/or measurements. While FIGS. 12A-12Dgenerally show three conductive wires for each clinical axis or side,other combinations are possible. For example, each of the clinical axesor sides can include a combination of conductive wires ranging from oneconductive wire to ten or more conductive members.

FIGS. 13 and 14 are perspective and exploded perspective views,respectively, of one embodiment of a device controller 19 consistentwith the present disclosure. As shown, the controller 19 may include afirst halve or shell 88 a and a second halve or shell 88 b for housing aPC board 90 within, the PC board 90 comprising circuitry and hardwarefor controlling various parameters of the device 14 during an ablationprocedure. The controller 19 further includes a display 92, such as anLCD or LED display for providing a visual representation of one or moreparameters associated with the device 14, including, but not limited to,device status (e.g., power on/off, ablation on/off, fluid deliveryon/off) as well as one or more parameters associated with the RFablation (e.g., energy output, elapsed time, timer, temperature,conductivity, etc.). The controller 19 may further include a topmembrane 94 affixed over the PC board 92 and configured to provide userinput (by way of buttons or other controls) with which a user (e.g.,surgeon or medical professional) may interact with a user interfaceprovided on the display 92. The controller 19 may be configured tocontrol at least the amount of electrical current applied to one or moreof the conductive wires 28 from the ablation generator 20 and the amountof fluid to be delivered to the device 14 from the irrigation pump/drip22.

FIG. 15 is an exploded perspective view of another embodiment of anablation device 14 a consistent with the present disclosure. The device14 a is similarly configured as device 14 illustrated in FIG. 8, andincludes similar elements. For example, the device 14 a includes thedistal tip 16 formed from two or more pieces (tip halves 16 a and 16 b)configured to be coupled to one another to form the unitary distal tip16. Each half 16 a and 16 b includes cooperating neck portions 24 a, 24b and spheroid bodies 26 a, 26 b, as well as a cap 52 to be coupled toboth halves 16 a and 16 b so as to fully enclose the interior of thedistal tip 16. As further illustrated, an electrical line 34 may beprovided for coupling the conductive wires 28 to the controller 18 andablation generator 20 and a fluid line 38 may be provided for providinga fluid connection between the irrigation pump or drip 22 to the distaltip 16 so as to provide a conductive fluid (e.g., saline) to the tip 16.The electrical line 34 and/or the fluid delivery line 38 can besupported by a stabilizing element 62 within the device lumen. In somecases, the stabilizing element 62 may be integral with the neck 24 ofthe distal tip 16.

The device 14 a is configurd to provide RF ablation via a virtualelectrode arrangement, which includes distribution of a fluid along anexterior surface of the distal tip 16 and, upon activation of theelectrode array, the fluid may carry, or otherwise promote, energyemitted from the electrode array to the surrounding tissue. For example,the nonconductive spheroid body 26 includes an interior chamber (whenthe first and second halves 26 a, 26 b are coupled to one another) forretaining at least a spacing member 96 (also referred to herein as“spacer ball”) and one or more hydrophilic inserts 98 a, 98 bsurrounding the spacing member 96. The interior chamber of the distaltip 16 is configured to receive and retain a fluid (e.g., saline)therein from a fluid source. The hydrophilic inserts 98 a, 98 b areconfigured receive and evenly distribute the fluid through the distaltip 16 by wicking the saline against gravity. The hydrophilic inserts 98a and 98 b can be formed from a hydrophilic foam material (e.g.,hydrophilic polyurethane).

As previously described, the distal tip 16 may generally include aplurality of ports or apertures configured to allow the fluid to passtherethrough, or weep, from the interior chamber to an external surfaceof the distal tip 16. Accordingly, in some embodiments, all of the ports(e.g., proximal ports 44, medial ports 45, and distal ports 46) may beconfigured to allow for passage of fluid from the inserts 98 a, 98 b tothe exterior surface of the distal tip 16. However, in some embodiments,only the medial ports 45 may allow for fluid passage, while the proximaland distal ports 44, 46 may be blocked via a heat shrink or otherocclusive material.

The spacer member 96 may formed from a nonconductive material and may beshaped and sized so as to maintain the hydrophilic inserts 98 a, 98 b insufficient contact with the interior surface of the distal tip wall, andspecifically in contact with the one or more ports, such that thehydrophilic inserts 98 a, 98 b provides uniformity of salinedistribution to the ports. In some embodiments, the spacer member 96 mayhave a generally spherical body, corresponding to the interior contourof the chamber of the spheroid body 26.

Accordingly, upon positioning the distal tip 16 within a target site(e.g., tissue cavity to be ablated), the electrode array can beactivated and fluid delivery can be initiated. The fluid weeping throughthe ports to the exterior surface of the distal tip is able to carryenergy from electrode array, thereby creating a virtual electrode.Accordingly, upon the fluid weeping through the port, a pool or thinfilm of fluid is formed on the exterior surface of the distal portionand is configured to ablate surrounding tissue via the RF energy carriedfrom the electrode array.

As previously described herein, conductive wires 28 may generally extendthrough a first port (e.g., the distal port 44), run along an externalsurface of the spheroid body 26 before re-entering the lumen of thedistal tip 16 through another port (e.g., the proximal port 46). FIGS.16, 17, 18A-18B, and 19A-19B illustrate another arrangement ofconductive wires 28, in which at least four different conductive wiresare provided, two of which serve as supply electrodes and the other twoserve as return electrodes. Each of the four different conductive wiresgenerally pass through at least two different proximal ports and twodifferent distal ports, while remaining isolated from one another. FIG.16 is a plan view of the ablation device 14 a illustrating the twohalves of the device tip 16 a, 16 b separated from one another andshowing the external surface each, while FIG. 17 shows the interiorsurface of each.

FIGS. 18A and 18B are enlarged views of the spheroid body of the firsthalve 16 a of the device 14 a showing the exterior and interiorsurfaces, respectively, and further illustrating the particulararrangement of first and second conductive wires 28(1) and 28(2), partlyin phantom, extending through proximal and distal ports 44, 46 of thespheroid body 26 a. The following description of the first and secondconductive wires 28(1) and 28(2) provides a general pathway of eachwire, including passages through ports and extensions along lengths ofthe interior and exterior surfaces of the tip 16. In the illustratedembodiment, a first conductive wire 28(1) may serve as a returnelectrode while a second conductive wire 28(2) may serve as a supplyelectrode.

As shown, the first conductive wire 28(1) extends within the lumen ofthe tip 16 a and passes through proximal port 44(1), extends along theexterior surface of the spheroid body 26 a towards the distal ports(generally parallel to longitudinal axis of device), passes throughdistal port 46(1), extends along the interior surface of the body 26 atowards adjacent distal ports (generally transverse to longitudinal axisof the device), passes through distal port 46(2), extends along theexterior surface of the spheroid body 26 a back towards the proximalports, passes through proximal port 44(2), extends along the interiorsurface of body 26 a towards adjacent proximal ports, passes throughproximal port 44(5), extends along the exterior surface of the spheroidbody 26 a back towards the distal ports, passes through distal port46(5), extends along the interior surface of the body 26 a towardsadjacent distal ports, passes through distal port 46(6), extends alongthe exterior surface of the spheroid body 26 a back towards the proximalports, passes through proximal port 44(6), and extends back throughlumen of the tip 16 a. Accordingly, the first conductive wire 28(1) hasat least four portions that extend along the exterior surface of thespheroid body 26 a.

The second conductive wire 28(2) extends within the lumen of the tip 16a and passes through proximal port 44(3), extends along the exteriorsurface of the spheroid body 26 a towards the distal ports (generallyparallel to longitudinal axis of device), passes through distal port46(3), extends along the interior surface of the body 26 a towardsadjacent distal ports (generally transverse to longitudinal axis of thedevice), passes through distal port 46(4), extends along the exteriorsurface of the spheroid body 26 a back towards the proximal ports,passes through proximal port 44(4), and extends back through lumen ofthe tip 16 a. Accordingly, the second conductive wire 28(2) has at leasttwo portions that extend along the exterior surface of the spheroid body26 a.

FIGS. 19A and 18B are enlarged views of the spheroid body of the secondhalve 16 b of the device 14 a showing the exterior and interiorsurfaces, respectively, and further illustrating the particulararrangement of third and fourth conductive wires 28(3) and 28(4)extending through proximal and distal ports of the spheroid body 26 b.The following description of the third and fourth conductive wires 28(3)and 28(4) provides a general pathway of each wire, including passagesthrough ports and extensions along lengths of the interior and exteriorsurfaces of the tip 16. In the illustrated embodiment, a thirdconductive wire 28(3) may serve as a return electrode while a secondconductive wire 28(4) may serve as a supply electrode.

As shown, the third conductive wire 28(3) extends within the lumen ofthe tip 16 a and passes through proximal port 44(9), extends along theexterior surface of the spheroid body 26 b towards the distal ports(generally parallel to longitudinal axis of device), passes throughdistal port 46(9), extends along the interior surface of the body 26 btowards adjacent distal ports (generally transverse to longitudinal axisof the device), passes through distal port 46(10), extends along theexterior surface of the spheroid body 26 b back towards the proximalports, passes through proximal port 44(10), and extends back throughlumen of the tip 16 a. Accordingly, the third conductive wire 28(3) hasat least two portions that extend along the exterior surface of thespheroid body 26 b.

The fourth conductive wire 28(4) extends within the lumen of the tip 16b and passes through proximal port 44(7), extends along the exteriorsurface of the spheroid body 26 b towards the distal ports (generallyparallel to longitudinal axis of device), passes through distal port46(7), extends along the interior surface of the body 26 b towardsadjacent distal ports (generally transverse to longitudinal axis of thedevice), passes through distal port 46(8), extends along the exteriorsurface of the spheroid body 26 b back towards the proximal ports,passes through proximal port 44(8), extends along the interior surfaceof body 26 b towards adjacent proximal ports, passes through proximalport 44(11), extends along the exterior surface of the spheroid body 26b back towards the distal ports, passes through distal port 46(11),extends along the interior surface of the body 26 b towards adjacentdistal ports, passes through distal port 46(12), extends along theexterior surface of the spheroid body 26 b back towards the proximalports, passes through proximal port 44(12), and extends back throughlumen of the tip 16 a. Accordingly, the fourth conductive wire 28(4) hasat least four portions that extend along the exterior surface of thespheroid body 26 b.

Furthermore, each of the four conductive wires 28(1)-28(4) remainelectrically isolated and independent from one another such that, each,or one or more sets of a combination of, the conductive wires, canindependently receive an electrical current from the ablation generatorand independently conduct energy, the energy including RF energy. Thisallows energy to be selectively delivered to a designated conductivewire or combination of conductive wires. This design also enables theablation device to function in a bipolar mode because a first conductivewire (or combination of conductive wires) can deliver energy to thesurrounding tissue through its electrical connection with an ablationgenerator while a second conductive wire (or combination of conductivewiress) can function as a ground or neutral conductive member.

The independent control of each wire or sets of wires allows foractivation (e.g., emission of RF energy) of corresponding portions ofthe electrode array. For example, the electrode array may be partitionedinto specific portions which may correspond to clinical axes or sides ofthe distal portion of the device. In one embodiment, the electrode arraymay include at least four distinct portions (i.e., individual or sets ofconductive wires) corresponding to four clinical axes or sides of thedistal portion (e.g, four sides or quadrants around spheroid body).

FIG. 20 is a schematic illustration of the ablation device 14 aillustrating delivery of fluid from the irrigation pump 22, ascontrolled by the controller 19, to the hydrophilic inserts 98 a, 98 bwithin the interior chamber of the distal tip 16, wherein the fluid canbe subsequently distributed to an exterior surface of the spheroid body26 resulting in a virtual electrode arrangement upon activation of oneor more portions of the electrode array. As shown, the saline may bedistributed through at least the medial ports 45, such that the weepingsaline is able to carry electrical current from electrode array, suchthat energy is transmitted from the electrode array to the tissue by wayof the saline weeping from the ports, thereby creating a virtualelectrode. Accordingly, upon the fluid weeping through the medial port,a pool or thin film of fluid is formed on the exterior surface of thespheroid body 26 and is configured to ablate surrounding tissue via theelectrical current carried from the electrode array.

FIGS. 21 and 22 are perspective and plan views of a detachable mount 100for holding and maintaining a temperature probe 102 (or any otherseparate monitoring device) at a desired position, as indicated by arrow106, relative to the spheroid body 26 of the distal tip of the ablationdevice 14. In particular, the mount 100 allows for an operator (e.g.,surgeon) to releasably couple a temperature probe 102, or othermeasurement device, to the ablation device 14 a and further position theworking end 104 of the probe 102 in close proximity to the spheroid body2 for the collection of temperature data during an RF ablationprocedure.

As previously described herein, the controller 18, 19 may be configuredto provide a surgeon with the ability to control ablation, such ascontrolling the supply of power to one or more conductive wires as wellas control the delivery of fluid to the device tip 16. Furthermore, thecontroller 18, 19 may provide device status (e.g., power on/off,ablation on/off, fluid delivery on/off) as well as one or moreparameters associated with the RF ablation (e.g., energy output, elapsedtime, timer, temperature, conductivity, etc.). Thus, in some instances,it may be important to monitor at least the temperature adjacent to thedevice tip 16 during the ablation procedure, as well as pre-ablation andpost-ablation, as temperature may be indicative of the status ofsurrounding tissue that is being, or is intended to be, ablated.Furthermore, it may be important to monitor the temperature at certaindistances from the device tip 14 and at certain angles. Current devicesmay include a thermocouple mechanism integrated into the device.However, such configurations lack the ability to obtain temperaturemeasurement at specific distances and angles relative to the ablationtip. The mount 100 is configured to provide a surgeon with the abilityto adjacent the angle at which the temperature probe is positionedrelative to the device tip 16 as well as the distance from the devicetip 16, thereby overcoming the drawbacks of integrated thermocouples.

As shown, the mount 100 generally includes a body having a first end 108configured to be releasably coupled to at least the proximal end of thedevice 14 by way of a clamping mechanism or latch-type engagement. Thefirst end 108 includes a top guard member 110 configured to partiallyenclose at least the proximal end of the device 14, to further enhancesecurement of the mount 100 to the device 14. The mount 100 furtherincludes an arm member 112 extending from the first end 108 andproviding a second end 114 positioned a distance from the first end 108.The second end 114 is configured to hold the temperature probe 102 at adesired position, including a desired distance from the spheroid body 26and a desired angle θ relative to the longitudinal axis of the ablationdevice. For example, in one embodiment, the second end 114 may include abore or channel configured to receive and retain a portion of thetemperature probe 102 within. The second end 114 may further allow forthe temperature probe 102 to translate along the bore or channel, asindicated by arrow 116, to thereby adjust the distance of thetemperature probe tip 104 relative to the spheroid body of the devicetip. In some embodiments, the arm 112 and/or second end 114 mayarticulate relative to one another and/or the first end 108.Accordingly, the angle of the temperature probe 102 may also be adjustedas desired.

Accordingly, tissue ablation devices, particularly the applicator headsdescribed herein, may be well suited for treating hollow body cavities,such as cavities in breast tissue created by a lumpectomy procedure. Thedevices, systems, and methods of the present disclosure can help toensure that all microscopic disease in the local environment has beentreated. This is especially true in the treatment of tumors that have atendency to recur.

The present disclosure includes ablation devices consistent with thepresent invention that have a refined design, which is amenable to fastand simple methods of manufacturing. Accordingly, the present disclosurealso provides methods for manufacturing such ablation devices.

FIG. 23 provides a schematic of an exemplary probe 2316 of an ablationdevice that can be manufactured using the methods of the invention. Theprobe 2316 may include a neck portion 2324 and a generally spheroid body2326 extending distally from the neck 2324. The neck 2324 may beconnected to a proximal shaft/handle portion 2380, which can, forexample, function as a handle manual manipulation or point of connectionto a surgical robot. The spheroid body 2326 may be generally rigid andmay maintain a default shape.

In some examples, the spheroid body 2326 includes a non-conductivematerial (e.g., a polyamide) as a layer on at least a portion of aninternal surface, an external surface, or both an external and internalsurface. In other examples, the spheroid body 2326 is formed from anon-conductive material. Additionally or alternatively, the spheroidbody 2326 material can include an elastomeric material or a shape memorymaterial.

In some implementations, the proximal shaft/handle portion 2380 can beconfigured as a handle adapted for manual manipulation by a medicalprofessional. Thus, the handle/shaft 2380 can include a texturedgripping surface 2383 to prevent the device from slipping in the hand.In some examples, the proximal shaft/handle portion 2380 is additionallyor alternatively configured for connection to and/or interface with asurgical robot, such as the Da Vinci® surgical robot available fromIntuitive Surgical, Inc., Sunnyvale, Calif. The catheter shaft/handle2380 may be configured to be held in place by a shape lock or otherdeployment and suspension system of the type that is anchored to apatient bed and which holds the device in place while the ablation orother procedure takes place, eliminating the need for a user to manuallyhold the device for the duration of the treatment.

As shown in FIG. 26, proximal shaft/handle portion 2380 can be shaped ortapered in a manner conducive to being held by a medical professional.

The probe 2316 further includes an electrode array disposed on thespheroid body 2326. The electrode array includes a plurality ofconductive members 2328. As shown, the plurality of conductive members2328 traverse from an interior space of the probe 2316 and are disposedalong an external surface of the spheroid body 2326. The conductivemembers 2328 extend along the longitudinal length of the spheroid body2326 and may be radially spaced apart (e.g., equidistantly spaced apart)from each other. These conductive members transmit RF energy from theablation generator and can be formed of any suitable conductive material(e.g., a metal such as stainless steel, nitinol, or aluminum).Preferably, the conductive members 2328 are metal wires. As shown, theprobe 2316 may be coupled to an ablation generator and/or irrigationpump via an electrical line 2334 and a fluid line 2338, respectively.

FIG. 24 provides an exploded perspective of probe 2316. As shown, thedistal portion can comprise two complementary, elongate body halves 2326a, 2326 b. These body halves act as the major structural feature of theprobe 2316 and serve as a chassis on which the remaining components ofthe portion are seated and secured. The two halves can be coupled orjoined to form a unitary distal portion.

As shown in FIG. 23, the elongate body halves 2316 a, 2316 b have beenjoined to create a unified probe 2316. Seam 2302 shows where the twohalve were joined. They may be joined via press-fit features and/orusing an adhesive.

Each body half includes a series of structures on the interior facingsurface. In certain aspects, some or all of these structures areintegral to the body halves. Among these structures are stabilizingelements 2362. In certain aspects, each body half 2316 a, 2316 bincludes cooperating stabilizing elements 2362. When the two halves arejoined, the cooperating stabilizing elements secure the two halves toone another. For example, the cooperating stabilizing elements 2362 mayinclude components such that the elements act as snap joints. Exemplarysnap joints include, for example, cantilever snap joints, U-shaped snapjoints, torsion snap joints, annular snap joints, and combinationsthereof.

In certain aspects, during manufacture, the two elongate body halves,with all components seated therein as described below, are broughttogether. By bringing the two halves together, the cooperating elementsare aligned and join the two halves without the need for additionalseals or sealants. This can greatly simplify manufacturing requirementswhen compared with prior devices. As shown in FIG. 23, in certainaspects, after joining the elongate body halves, a recessed screw can beused to reinforce or tighten the halves together.

In certain aspects, one or more of the stabilizing elements 2362 providefunctions, alternatively or additionally, to joining the elongate bodyhalves 2316 a, 2316 b. For example, one or more of the stabilizingelements 2362 may serve to provide the probe 2316 with structuralrigidity and integrity.

As shown in FIG. 25, in certain aspects stabilizing elements 2362 canserve to position, direct, and/or secure components of the device (e.g.,wires and tubes) within the interior space of the probe.

As shown in FIG. 24, the device further includes two wire harnesses 2381a, 2381 b. Each wire harness includes a plurality of electricallyisolated wires. Each wire includes a conductive distal end 2382. Incertain aspects, the conductive distal ends 2382 are provided aspreformed loops. These conductive distal ends are used to form theconductive members (electrodes) 2328.

During manufacturing, the conductive distal ends 2382 of each wire arepassed through an interior surface of the probe 2316 to the exterior.The conductive distal ends 2382 may pass through the interior surfacevia a series of slots or ports 2379 on the probe 2316. Each conductivedistal end 2382 is looped around a different anchor member 2384 disposedon the distal end of the spheroid body. As a result, two portions ofeach conductive distal end 2328 a, 2328 b are disposed along a surfaceof the spheroid body 2326.

In certain aspects, during manufacturing, the conductive distal end 2382of each wire is passed around an anchor element 2384 affixed to thespheroid body. In certain aspects, the conductive distal end 2382 ofeach wire is positioned on the spheroid body 2326 as a loop, and ananchor element 2384 is affixed to the spheroid body to secure the loop.

In certain aspects, each anchor element is permanently secured orintegral to one spheroid body half 2326 a, 2326 b. Alternatively, eachanchor element is secured or affixed to a spheroid body half duringmanufacturing. Each anchor element may be made from, or secured using, ajoining element, e.g., a screw or snap. The anchoring element may beconductive or nonconductive, and it may be formed onto the end of thewire.

In certain aspects, affixing the anchor element 2384 to the spheroidbody secures the looped conductive distal ends 2382 of a wire to thespheroid body. In certain aspects, the conductive distal ends are loopedaround an anchor element and secured by manipulating the anchor element2384, e.g., via tightening a fastening element such as a screw.

In certain aspects, the anchor element 2384 is made from anon-conductive material to ensure that RF energy is only transmittedfrom the conductive elements 2328 disposed on the spheroid body. Incertain aspects, the anchor element 2384 is made using a conductivematerial such that it can transmit RF energy during an ablationprocedure.

As shown in FIG. 24, each wire harness 2381 a, 2381 b includes a centralportion 2385 that is seated during manufacturing in the interior spaceof one of the elongate body halves 2316 a, 2316 b. In certain aspects,the interior space of each elongate body half includes one or more wirechannels or guides 2386 that secure the wires of each harness to anelongate body half. Also or alternatively, one or more of thestabilizing elements 2362 can be used to position the wires of theharness within the device. The channels, guides, and/or stabilizingelements can assure that, not only are the wires of each harnesspositioned correctly and secured within the device, but that they alsoremain electrically isolated from one another.

As also shown in FIG. 24, each wire harness includes a proximal end2387. The wires at the proximal end 2387 can be connected to the centralelectrical line 2334, which can in turn be connected to a devicecontroller 18 and/or an ablation energy generator 20. The connectionbetween the proximal end 2387 of a wire harness can be made or securedusing, for example, clips or wire fasteners 2388. In certain aspects,the clips/fasteners 2388 are integral to the elongate body halves.Alternatively, as shown in FIG. 24, the clips/fasteners can be seatedinto the elongate body halves during manufacturing. Theseclips/fasteners may be made using conductive components that mate whenthe two halves come together. The wires may terminate in theseconductive components and may complete the electrical connection betweenthe distal electrodes and the cable which leads to the energy source.

In certain aspects, one or more of a wire channel/guide 2386, astabilizing element 2362, and/or the fastener/clip 2388 are used toprovide a tensioning force on the wire harness towards the proximal endof the device. This helps ensure that the conductive distal tips 2382remain flat along the exterior surface of the spheroid body.

As illustrated, one or more of the conductive wires 2328 can beelectrically isolated from one or more of the remaining conductive wires2328. This electrical isolation enables various operation modes for theablation device. For example, ablation energy may be supplied to one ormore conductive wires 2328 in a bipolar mode, a unipolar mode, or acombination bipolar and unipolar mode. In the unipolar mode, ablationenergy is delivered between one or more conductive wires 2328 on theablation device 14 and the return electrode 15, as described withreference to FIG. 1. In bipolar mode, energy is delivered between atleast two of the conductive wires 2328, while at least one conductivewire 2328 remains neutral. In other words, at least, one conductive wirefunctions as a grounded conductive wire (e.g., electrode) by notdelivering energy over at least one conductive wire 2328.

Furthermore, because the wires remain electrically isolated andindependent from one another each, or one or more sets of a combination,of the conductive wires can independently receive an electrical currentfrom the ablation generator and independently conduct RF energy. Thisallows energy to be selectively delivered to a designated conductivewire or combination of conductive wires. This design also enables theablation device to function in a bipolar mode because a first conductivewire (or combination of conductive wires) can deliver energy to thesurrounding tissue through its electrical connection with an ablationgenerator while a second conductive wire (or combination of conductivewiress) can function as a ground or neutral conductive member.

The independent control of each wire or sets of wires allows foractivation (e.g., emission of RF energy) of corresponding portions ofthe electrode array. For example, the electrode array may be partitionedinto specific portions which may correspond to clinical axes or sides ofthe distal portion of the device. While various conductive wires 2328have generally been described such that individual conductive membersare energized or that the desired combination of conductive members isenergized for a pre-selected or desired duration, in some cases, thedesired combination of conductive members can be based on desiredcontact region of the spheroid body 2326.

Thus, as evident in FIG. 25, the conductive elements 2328 can bearranged and controlled in the same manner as those in FIGS. 18-19.However, advantageously, when manufacturing probe 2316, there is norequirement for the complex weaving of wires throughout the spheroidbody to provide the desired conductive element array. Rather, thepreformed wire harnesses 2381 can be used. The harnesses can haveelectrically isolated wires already bundled and cut to the properlengths such that they can be easily seated and secured within theelongate body halves 2316 a, 2316 b. Further, rather than weaving a longwire to provide a series of conductive elements, the distal conductivetips of each wire in a harness can be looped around an anchor member,such that two resulting conductive members are formed and disposed onthe spheroid body in a desired conformation.

As such, these devices of the disclosure can be manufactured faster andcheaper than prior devices. Moreover, as the methods of manufacturingare simple and involve fewer steps, there is less likelihood thatmistakes will occur during production. This not only provides moreconsistency across the manufactured devices, but also provides theability to employ a less skilled, and consequently less costly laborforce.

In certain aspects, these simple-to-manufacture devices can beconfigured to receive a flow of conductive and/or irrigation fluid, forexample, from an irrigation or pump 22 as described herein. As shown inFIG. 23, the fluid can be provided to a fluid line 2338, which isfluidically connected with the interior of the device. The fluid (e.g.,saline) may be provided to the probe 2316 where it may distributedthrough one or more ports or slots on the spheroid body 2326. In certainaspects, the spheroid body 2326 includes distal ports/slots, proximalports/slots, and/or medial ports/slots from which fluid is delivered tothe exterior of the spheroid body. The fluid flowing to the outersurface of the probe 2316 may carry electrical current from theelectrode array, such that energy is promoted from the electrode arrayto the tissue by way of the fluid, thereby creating a virtual electrode.Accordingly, upon the fluid weeping through the ports, a pool or thinfilm of fluid is formed on the exterior surface of the probe 2316 and isconfigured to ablate surrounding tissue via the electrical currentcarried from the electrode array.

As shown in FIGS. 24 and 25, the fluid line 2338 may be fluidicallyconnected to, or is a part of, a proximal lumen 2389. Duringmanufacturing, the proximal lumen 2389, which may be a flexible tube,can be easily seated and secured into an elongate body half using one ormore stabilizing structures 2362 and/or channels 2366. The proximallumen 2389 may be fluidically connected to a distal lumen 2390 toprovide fluid to the spheroid body 2326. Like the proximal lumen 2389,the distal lumen 2390 can be seated and secured using channels and/orstabilizing structures. The two lumens can be joined using a fluidicconnector 2391 seated between the lumens. The fluidic connector may beor may include, for example, a nozzle, flange, valves and the like. Thefluidic connector may create a leak tight or air tight seal between thetwo halves, with or without the aid of adhesive or liquid silicone, toprevent liquid from traveling up the handle.

In certain aspects, to facilitate electrical isolation and positioningof the wire harness wires, the fluidic connector 2391 may include wireguides 2392 that receive the wires during manufacturing.

As also shown in FIG. 24, like other devices disclosed herein, thedevice includes one or more hydrophilic inserts 2398 a, 2398 b that areseated within the spheroid body 2326. When seated in the spheroid body,the hydrophilic insert(s) aligns with the distal lumen 2390. Thehydrophilic insert is configured to distributed fluid from the distallumen to the exterior of the spheroid body, for example, by wicking thefluid against gravity. By using a wicking action, the hydrophilicinsert(s) provides a more uniform distribution of saline. In certainaspects, the hydrophilic insert(s) is formed using a hydrophilic foammaterial (e.g., hydrophilic polyurethane).

As shown in FIG. 24, in certain aspects, the hydrophilic insert isspherical and provided as two halves 2398 a, 2398 b. Duringmanufacturing, one half of the insert can be seated in the spheroid body2326 a, 2326 b of an elongate body half 2316 a, 2316 b. Each insert halfmay include one or more structures, such as slot 2397. Slot 2397 canseat around a corresponding structure 2396 in the spheroid body 2326 a,2326 b of an elongate body half. In certain aspects, the structures,such as slot 2397, facilitate an even distribution of fluid, despite theorientation of the probe, and provide some resistance to the fluid toprevent it from flowing too quickly. Similarly, in certain aspects, thehydrophilic insert includes one or more passages or ports 2360 thatfacilitate fluid distribution.

As previously described, the probe 2316, including the spheroid body2326, may generally include a plurality of ports or apertures configuredto allow the fluid to pass therethrough, or weep, from an interior spaceof the spheroid body to an external surface of the distal portion 2316.Accordingly, in some embodiments, all of the ports (e.g., proximalports, medial ports, and distal ports) may be configured to allow forpassage of fluid from the inserts 2398 a, 2398 b to the exterior surfaceof the probe 2316. However, in some embodiments, only the medial portsmay allow for fluid passage, while the proximal and distal ports may beblocked via a heat shrink or other occlusive material.

In certain aspects, the hydrophilic insert(s) surround a spacing member.The spacing member may, for example, help keep the hydrophilic insertflush against the interior space of the spheroid body. Alternatively,the hydrophilic insert may be adhered to the spacer ball. The spacingmember 2372 may be formed from a nonconductive material and may beshaped and sized so as to maintain the hydrophilic inserts 2398 a, 2398b in sufficient contact with the interior surface of the distal spheroidbody wall, and specifically in contact with the one or more fluid ports,such that the hydrophilic inserts 2398 a, 2398 b provide uniform fluiddistribution to the ports.

As shown in FIG. 24, in certain embodiments, the spacing member 2372 mayhave a generally spherical body, corresponding to the interior contourthe spheroid body 2326. In certain aspects, the spacer member includesstructural components 2371 that facilitate fluid distribution to thehydrophilic inserts. The structural components may align, for example,with a passage or port 2360 on the inserts to facilitate fluiddistribution.

As shown in FIG. 24, in certain methods of manufacturing the device, thespacing member 2372 is seated between two halves of a sphericalhydrophilic insert 2398 a, 2398 b.

As shown in FIG. 25, the spacer member may include one or more joiningmembers 2373, e.g., clips or snaps. During manufacturing the joiningmembers can be used, for example, to attach the halves of thehydrophilic insert to the spacer member such that insert halves surroundthe spacer member.

As shown in FIG. 24, in certain aspects, the device includes a distalcap 2352. During manufacture, the distal cap 2352 can be attached to thedistal end of the spheroid body. The cap may have a convex shape thatprovides an atraumatic surface on the distal end of the spheroid body.

As shown in FIG. 25, the distal cap 2352 may include a series ofradially distributed cutouts or depressions 2353. The anchor members2384 are affixed to the spheroid body 2326 such that when the cap 2352is attached the anchor members are disposed within the cutouts ordepression 2353. As such, the anchor members 2384 do not protrude beyondthe distal cap 2352, thereby preserving the atraumatic tip. In certainaspects, attaching the cap secures the wire loops in place around theanchor members.

Consistent with the other devices of the invention, fluid from theirrigation pump 22, as controlled by the controller 19, is delivered tothe hydrophilic inserts 2398 a, 2398 b within the interior space of theprobe 2316. The device controller 18 may be used to control the emissionof energy from one or more conductive members of the device to result inablation, as well as controlling the delivery of fluid to the applicatorhead, i.e., the spheroid body 2326, so as to control subsequent weepingof fluid from the probe 2316 during an RF ablation procedure. In somecases, the device controller 18 may be housed within the ablationdevice. With reference to FIG. 1, the ablation generator 20 may alsoconnected to a return electrode 15 that is attached to the skin of thepatient 12. During an ablation treatment, the ablation generator 20 maygenerally provide RF energy (e.g., electrical energy in theradiofrequency (RF) range (e.g., 350-800 kHz)) to the conductive wires2328 of the ablation device, as controlled by the device controller 18.At the same time, saline may also be released from the probe 2316. TheRF energy travels through the blood and tissue of the patient 12 to thereturn electrode 15 and, in the process, ablates the region(s) oftissues adjacent to portions of the electrode array that have beenactivated.

The probe 2316 may be coupled to the ablation generator and/or theirrigation pump via an electrical line 2334 and a fluid line 2338,respectively. Each of the electrical line 2334 and fluid line 2338 mayinclude an adaptor end, respectively, configured to couple theassociated lines with a respective interface on the ablation generatorand irrigation pump. In some examples, the ablation device may furtherinclude a user switch or interface which may serve as the devicecontroller and thus, may be in electrical communication with theablation generator and the ablation device, as well as the irrigationpump for controlling the amount of fluid to be delivered to the tip ofthe probe 2316.

The switch can provide a user with various options with respect tocontrolling the ablation output of the device. For example, the switch,which may serve as the device controller, may include a timer circuit,or the like, to enable the conductive wires 2328 to be energized for apre-selected or desired amount of time. After the pre-selected ordesired amount of time elapses, the electrical connection can beautomatically terminated to stop energy delivery to the patient. In somecases, the switch may be connected to individual conductive wires 2328.For example, in some embodiments, the switch may be configured tocontrol energy delivery from the ablation generator so that one or moreindividual conductive wires, or a designated combination of conductivewires, are energized for a pre-selected, or desired, duration.

As shown in FIG. 27, in certain aspects, the device includes a pluralityof support structures 2375 disposed on the spheroid body 2326. Thesupport structures may include a proximal end attached to the spheroidbody 2326 and a distal end secured to the spheroid body via the anchormember 2384. In certain aspects, the support structures are flexible.During manufacture, the distal end of the support structures 2375 can beaffixed to the spheroid body 2326 via the anchor and thereby secure aconductive wire loop as described herein.

As shown in FIG. 27, the conductive wires may be disposed on thespheroid body 2326 along the lateral edges of the support structures2375. The support structures 2375 may be made from a non-conductivematerial, such as that used to produce the spheroid body 2326.Alternatively, the support structures 2375 are made using a conductivematerial (e.g., metal such as stainless steel, nitinol, or aluminum) toallow RF energy to transmit from the conductive wires 2328 to thesupport structures. In such instances, the conductive wires can bedisposed between the spheroid body and the support structures to providea smoother working surface with broad electrodes. The distal portions ofthe support structures 2375 may be affixed to the spheroid body withinthe cutouts/depressions 2353 of the distal cap 2352. Thus, the supportstructures can be recessed from the cap 2352, such that they do notprotrude and create a traumatic surface. In certain aspects, when thecap 2352 and support structures are shaped such that when they are bothaffixed to the spheroid body, they form a smooth and continuousatraumatic surface.

In certain aspects, the controller may be powered by a battery and thebattery may be held in place using an overlay. The overlay may contain aperforated section that allows the user to tear away a portion of theoverlay in order to remove the battery after use. The overlay may have afoam backing which prevents fluid ingress from seeping into the batteryslot. The overlay's perforation may be located outside of the batterywindow in order to prevent fluid ingress.

As used in any embodiment herein, the term “controller”, “module”,“subsystem”, or the like, may refer to software, firmware and/orcircuitry configured to perform any of the aforementioned operations.Software may be embodied as a software package, code, instructions,instruction sets and/or data recorded on non-transitory computerreadable storage medium. Firmware may be embodied as code, instructionsor instruction sets and/or data that are hard-coded (e.g., nonvolatile)in memory devices. “Circuitry”, as used in any embodiment herein, maycomprise, for example, singly or in any combination, hardwiredcircuitry, programmable circuitry such as computer processors comprisingone or more individual instruction processing cores, state machinecircuitry, and/or firmware that stores instructions executed byprogrammable circuitry. The controller or subsystem may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), system on-chip (SoC),desktop computers, laptop computers, tablet computers, servers, smartphones, etc.

Any of the operations described herein may be implemented in a systemthat includes one or more storage mediums having stored thereon,individually or in combination, instructions that when executed by oneor more processors perform the methods. Here, the processor may include,for example, a server CPU, a mobile device CPU, and/or otherprogrammable circuitry.

Also, it is intended that operations described herein may be distributedacross a plurality of physical devices, such as processing structures atmore than one different physical location. The storage medium mayinclude any type of tangible medium, for example, any type of diskincluding hard disks, floppy disks, optical disks, compact diskread-only memories (CD-ROMs), compact disk rewritables (CD-RWs), andmagneto-optical disks, semiconductor devices such as read-only memories(ROMs), random access memories (RAMs) such as dynamic and static RAMs,erasable programmable read-only memories (EPROMs), electrically erasableprogrammable read-only memories (EEPROMs), flash memories, Solid StateDisks (SSDs), magnetic or optical cards, or any type of media suitablefor storing electronic instructions. Other embodiments may beimplemented as software modules executed by a programmable controldevice. The storage medium may be non-transitory.

As described herein, various embodiments may be implemented usinghardware elements, software elements, or any combination thereof.Examples of hardware elements may include processors, microprocessors,circuits, circuit elements (e.g., transistors, resistors, capacitors,inductors, and so forth), integrated circuits, application specificintegrated circuits (ASIC), programmable logic devices (PLD), digitalsignal processors (DSP), field programmable gate array (FPGA), logicgates, registers, semiconductor device, chips, microchips, chip sets,and so forth.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in oneembodiment” or “in an embodiment” in various places throughout thisspecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments.

The terms and expressions which have been employed herein are used asterms of description and not of limitation, and there is no intention,in the use of such terms and expressions, of excluding any equivalentsof the features shown and described (or portions thereof), and it isrecognized that various modifications are possible within the scope ofthe claims. Accordingly, the claims are intended to cover all suchequivalents.

What is claimed is:
 1. A method for manufacturing a medical device, themethod comprising: providing elongate body comprising an interior spaceas two complimentary halves, wherein each half comprises a spheroid bodyat a distal end; providing two wire harnesses, each wire harnesscomprising a plurality of electrically isolated wires, each wirecomprising a conductive distal end; looping the conductive distal end ofeach wire around an anchor member disposed on a distal portion of thespheroid body of one of the complimentary body halves, such that twoportions of each conductive distal end are disposed along a surface ofthe spheroid body; and joining the two complimentary halves.
 2. Themethod of claim 1, wherein the conductive distal ends of each wire arepreformed loops.
 3. The method of claim 2, wherein looping theconductive distal end of a wire comprises disposing a preformed loopalong the exterior surface of the spheroid body and fastening the anchorto a distal portion of the spheroid body.
 4. The method of claim 1,wherein looping the conductive distal end of a wire comprises passingthe conductive distal end from the interior space of an elongate bodyhalf to an exterior side, distally along the exterior surface of thespheroid body, around the anchor member, proximally along the exteriorsurface, and through the body into the interior space.
 5. The method ofclaim 1, wherein prior to joining the complimentary halves, each wireharness is connected to a central electrical wire disposed within theinterior space of the elongate body.
 6. The method of claim 5, wherein aportion of each wire harness is seated within one or more channelsdisposed on an interior surface of an elongate body half.
 7. The methodof claim 6, wherein a portion of central wire is seated within one ormore channels disposed on an interior surface of an elongate body half.8. The method of claim 1, wherein prior to joining the complimentaryhalves, the method further includes seating a hydrophilic insert in atleast one spheroid body.
 9. The method of claim 8, wherein thehydrophilic insert is spheroid.
 10. The method of claim 9, wherein thehydrophilic insert comprises a spherical spacer ball disposed within aninterior of the insert.
 11. The method of claim 10, wherein thehydrophilic insert is provided as two complementary halves that arejoined around the spacer prior to seating.
 12. The method of claim 8,further comprising seating at least one fluid lumen within the interiorspace of an elongate body half
 13. The method of claim 12, wherein themethod comprises seating a distal fluid lumen and a proximal fluid lumeninto the interior space of the elongate body half and fluidicallyconnecting the lumens.
 14. The method of claim 13, wherein the lumensare connected using a fluidic connector seated between the lumens. 15.The method of claim 1, wherein after joining the elongate body halves,the method further comprises seating a distal cap on the distal end ofthe joined spheroid bodies.
 16. The method of claim 15, wherein seatingthe distal cap secures the looped conductive distal ends around theanchor members.
 17. The method of claim 1, wherein the distal spheroidbodies comprise a plurality of support members, each member extendingfrom a proximal portion of the spheroid body to the distal portion,wherein a distal end of each member is attached to the distal portion ofthe spheroid body via one of the anchor members.
 18. The method of claim17, wherein the method further comprises passing each of the twoconductive wire portions of each wire along a lateral surface of one ofthe support members.
 19. The method of claim 17, wherein the methodfurther comprises passing each of the two conductive wire portions ofeach wire underneath a one or the support members.
 20. The method ofclaim 19, wherein the support members are conductive.